The ossicular replacement prosthesis should have good biocompatibility, stability, easy to install, and excellent sound transmission capacity. In this study, the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures. At the same time, in combination with the current evaluation requirements and evaluation experience, the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products, so as to provide reference for the future work of manufacturers and regulators. The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties, fixation stability, sound transmission characteristics, biological characteristics, and magnetic resonance compatibility.
Ossicular Prosthesis ; Ossicular Replacement ; Sound ; Prosthesis Design ; Treatment Outcome

OBJECTIVE: To evaluate the results in patients who had ossicular chain reconstruction with a new type ossicular prostheses mixed bone morphogenetic protein and hydroxyapatite. METHOD: Analyze The effect of ossiculoplasty were analyzed in 59 cases. Ossiculoplasty using HA-BMP prostheses was performed in 26 ears,PORP was performed in 19 ears, TORP was performed in 7 ears. RESULT: The hearing success rate was 92.3% of 26 ears and no extrusion were found in HA-BMP group. There was a significant difference in mean postoperative air-bone gap between HA-BMP prostheses and autograft bone. CONCLUSION The new type HA-BMP prostheses can provide stable hearing results with high success rate over time.
Adult ; Bone Morphogenetic Proteins ; Bone Substitutes ; Female ; Humans ; Male ; Ossicular Prosthesis ; Ossicular Replacement ; Tympanoplasty

BACKGROUD AND OBJECTIVES: Incus erosion with intact stapes head was most common ossicular impairment in chronic otitis media. Here, we aimed to investigate hearing and clinical results of the ossiculoplasties when the stapes head was intact. SUBJECTS AND METHOD: We analyzed 281 patients of ossiculoplasties over stapes head performed from 1990 to 2005. Patients were divided into 3 groups: Si group (n=121) included patients with interposition of prosthesis between malleus and stapes; Sc-PORP group (n=99) included patients with columellarization between tympanic membrane and stapes head with PORP; Sc-SC group (n=61) included patients with columellarization with the autologous materials between tympanic membrane and stapes head. Hearing improvement and extrusion rates of three groups were analyzed. RESULTS: At 6 months after the surgery, the postoperative air-bone gap (ABG) level within 20 dB was 45%, 44%, 25% in Si, Sc-PORP, Sc-Sc, respectively. The closure of ABG was statistically better in Si and Sc-PORP compared with Sc-SC. In canal wall-up mastoidectomy, Sc-PORP showed better hearing results than Si, while Si was better than Sc-PORP in canal wall-down mastoidectomy. At 36 months after the surgery, extrusion-free survival according to the type of ossiculoplasty were 100%, 89.6%, 100% in Si, Sc-PORP, Sc-SC, respectively. CONCLUSION: Si and Sc-PORP provide good hearing results. However, Si has lower extrusion rates than Sc-PORP and remains stable over time.
Head ; Hearing ; Humans ; Incus ; Malleus ; Ossicular Prosthesis ; Ossicular Replacement ; Otitis Media ; Prostheses and Implants ; Stapes ; Tympanic Membrane

BACKGROUND AND OBJECTIVES: Multiple techniques of ossicular replacement have been advocated for hearing gain in the setting of chronic otitis media. The purpose of this study is to investigate hearing gain in the middle ear surgery according to the surgical technique and the materials. MATERIALS AND METHOD: Ninety-nine cases with ossicular replacement with mastoidectomy in the Konkuk University Hospital from 1995 to 2001 were reviewed retrospectively. Postoperative hearing gains were compared with the two methods of mastoidectomy and the two materials of ossicular replacement separately. RESULTS: A successful hearing gain was defined as a postoperative air-bone gap less than 30dB. According to this criterion, 47% of intact canal wall mastoidectomy cases and 43% of open cavity mastoidectomy cases were successful. Thirty-one percent of ossicular replacement case using cartilage-perichondrium and 62% using hydroxyapatite-PORP were successful. The extrusion rate was zero % in ossicular replacement using cartilage-perichondrium, and 57% in ossicular replacement using PORP. CONCLUSION: There was a significant differences in hearing gain and extrusion rate by using two different materials for ossicular replacement such as cartilage and hydroxyapatite-PORP (p<0.05). There was no statistically significant differences in hearing gain between the two methods of mastoidectomy (p>0.05).
Cartilage ; Ear, Middle ; Hearing* ; Incus* ; Malleus* ; Ossicular Prosthesis ; Ossicular Replacement ; Otitis Media ; Retrospective Studies

BACKGROUND AND OBJECTIVES: During the last decade, the surgical use of alloplasts has become more and more widespread among otologists. In this study, we evaluated the hearing results of ossiculoplasty using Polycel(R) prosthesis. SUBJECTS AND METHOD: One hundred eighty eight cases who underwent ossicular chain reconstruction using Polycel(R) prosthesis and had been followed up postoperatively for more than 12 months at Severance Eye-ENT Hospital from 1998 to 2002 were reviewed retrospectively. Postoperative hearing results were assessed by measuring the postoperative air-bone gap (ABG) and closure in air-bone gap. Successful postoperative ABG criteria were defined as the following three groups ; ABG of < or =10 dB, ABG of < or =20 dB, and ABG of < or =30 dB. Several prognostic factors such as the condition of middle ear mucosa and ossicles, presence or absence of cholesteatoma, surgical method, staging and revision surgery were analyzed. RESULTS: Of the total of 188 cases, 22 cases (11.7%) were < or =10 dB ABG, 96 (51.1%) cases were < or =20 dB ABG, and 158 (84.0%) cases were < or =30 dB ABG. The hearing results were good for healthy middle ear mucosa and cases which contained stapes superstructure, the hearing results were Good. CONCLUSION: Polycel(R) is a good material to be used in ossiculoplasty as a hydroxyapatite and autologous bone. In ossiculoplasty, good prognostic factors of the middle ear condition were healthy middle ear mucosa and the presence of stapes superstructure.
Audiometry ; Cholesteatoma ; Durapatite ; Ear, Middle ; Hearing* ; Mucous Membrane ; Ossicular Prosthesis ; Ossicular Replacement ; Polyethylene ; Prostheses and Implants* ; Retrospective Studies ; Stapes

BACKGROUND AND OBJECTIVES: Tympanosclerosis is a nonspecific and irreversible result of chronic inflammation or infection of the middle ear. However, there remains disagreement about how best to surgically treat tympanosclerotic ossicular fixation, with the controversy over its management when stapes is involved. The aim of this study was to evaluate operative findings and hearing results of tympanosclerosis involving the ossicular chain, which in turn would establish better surgical treatment of tympanosclerotic ossicular fixation. SUBJECTS AND METHODS: In this prospective study conducted from Mar 2000 to Dec 2007, 38 patients with tympanosclerosis who had undergone surgical treatment were evaluated. The clinical and operational records and pre- and postoperative pure tone audiograms were reviewed. RESULTS: Operative findings showed stapes fixation is the most common. In 8 patients (21.1%), stapes was mobile, while, in the remaining 30 patients (78.9%), stapes fixation was found. In all cases with stapes fixation, stapes mobilization was possible. Following hearing result reporting guideline by the Korean Otological Society, the success rate of middle ear surgery was 68.4% (26 of 38 patients). In cases with stapes fixation, the success rate was 66.6% (20 of 30 patients), while, in cases with no stapes fixation, the success rate was 75.0% (6 of 8 patients). However, there was no statistical significance between the two groups. CONCLUSION: Stapes fixation was found in 78.9% of tympanosclerotic ossicular fixation. In management of tympanosclerotic stapes fixation, meticulous excision of tympanosclerotic plaques and removal of new bone formation around stapes footplate after adequate exposure could achieve a relatively good hearing result without stapes surgery.
Ear, Middle ; Hearing ; Humans ; Inflammation ; Myringosclerosis ; Ossicular Replacement ; Osteogenesis ; Prospective Studies ; Stapes ; Stapes Mobilization ; Stapes Surgery

BACKGROUND AND OBJECTIVES: Various materials have been used for ossicular reconstruction, but there have been no reports for titanium prosthesis in South Korea. The purpose of this study was to assess the hearing results of Kurz titanium prosthesis in chronic ear diseases. SUBJECTS AND METHOD: A retrospective review was made of 62 cases who underwent ossicular reconstruction using either titanium (TTP(R)-VARIO System) or plastipore (Polycel(R)) prosthesis from January 2003 to July 2005. Postoperative hearing results were analyzed taking in several prognostic factors such as the condition of middle ear mucosa and ossicle, or surgical method. RESULTS: A postoperative air-bone gap of E20 dB was obtained in 75.6% of the titanium and 56% of plastipore ossiculoplasty. The Postoperative ABG (air bone gap) show better results in healthy middle ear mucosa and in those cases which contain stapes superstructure. CONCLUSION: Titanium have a good biocompatibility and low extrusion rates with excellent hearing results. Besides, good visualization and accurate placement were easy to achieve.
Ear Diseases ; Ear, Middle ; Hearing ; Korea ; Mucous Membrane ; Ossicular Replacement ; Prostheses and Implants* ; Retrospective Studies ; Stapes ; Titanium*

OBJECTIVE: To assess hearing effect of ossicular chain reconstruction with titanium ossicular replacement prosthesis during mastoidectomy with synchronous ossiculoplasty in chronic middle ear disease. METHOD: Retrospective reviews were performed for 139 patients who had underwent mastoidectomy and tympanoplasty with titanium ossicular replacement prostheses at the same time between 2008 and 2011. The partial ossicular replacement prostheses (PORP) were used in 91 patients and the total ossicular replacement prostheses (TORP) were used in 48 patients respectively. All patients had follow-up for 2 to 5 years. The preoperative and postoperative mean air conduction and air-bone gaps(ABG) for the four frequencies (0.5, 1.0, 2.0 and 4.0 kHz) were evaluated. The improvement of mean air conduction and ABG over the same frequencies were measured. A postoperative ABG less than or equal to 20 dB was considered a successful operation. The hearing results of titanium PORP and TORP were compared. RESULT: The mean air conductions were (53.97 +/- 11.32)dB and (36.80 +/- 11.68) dB preoperatively and postoperatively in PORP group. The mean improvement in air conduction was (17.17 +/- 5.79)dB. The mean ABG was (31.84 +/- 6.17)dB and (15.13 +/- 7.22)dB preoperatively and postoperatively in PORP group. The mean improvement in ABG was (17.71 +/- 5.5)dB. The difference of hearing threshold between preoperative and postoperative had statistical significance (P < 0.01). The mean air conduction were (58.05 +/- 11.35)dB and (44.53 +/- 13.15)dB preoperatively and postoperatively in TORP group. The mean improvement in air conduction was (13.52 +/- 7.81)dB. The mean ABG; were (35.67 +/- 5.73)dB and (21.48 +/- 7.01)dB preoperatively and postoperatively for TORP group. The mean improvement of hearing threshold in ABG was (14.18 +/- 7.53)dB. The difference of hearing threshold between preoperative and postoperative had statistical significance (P < 0.01). ABG less than 20 dB after operationwas happened in 68.63% of the patients (74.73% for PORP and 54.17% for TORP). There was statistically significant difference between PORP and TORP (P < 0.05). CONCLUSION We conclude that titanium ossicular reconstruction during mastoidectomy with synchronous ossiculoplasty give stable and excellent hearing results. We obtained better results with PORP than with TORP.
Adolescent ; Adult ; Aged ; Child ; Female ; Follow-Up Studies ; Humans ; Male ; Mastoid ; surgery ; Middle Aged ; Ossicular Prosthesis ; Ossicular Replacement ; methods ; Retrospective Studies ; Titanium ; Treatment Outcome ; Tympanoplasty ; methods ; Young Adult

OBJECTIVE: To investigate the diagnose therapy and the postoperative curative effect of traumatic ossicular chain disruption and dislocation. METHOD: Eight cases (8 ears) with traumatic ossicular chain disruption. Six cases of unilateral conductivity deafness, 2 of mixed deafness still with conductive primarily. Eight ears all were performed tympanic exploration and ossicular replacement prosthesis, 1 ear with TORP (total ossicular replacement prosthesis). 4 ears with PORP (partial ossicular replacement prosthesis), 2 with ossicular chain reset, 1 with artificial incus reconstruction. The treatment effect was compared by the preoperative and postoperative ABG (air bone gap). RESULT: Preoperative average ABG was 42. 9 dB, the average ABG 3 weeks after operation was 22.3 dB, which reduced 20.6 dB compared to the preoperative, having a statistically significant difference (t = 22.10, P < 0.01). The average ABG was 18.6 dB 6-8 months after operation, which reduced 24.3 dB compared to the preoperative, having a statistically significant difference (t = 12.813, P < 0.01). CONCLUSION The conductivity hearing loss after traumatic ossicular chain disruption or dislocation is preferred operation treatment, and replacement should use different ways according to the operation in case, and the hearing improvement was obvious.
Adolescent ; Adult ; Bone Conduction ; Ear Ossicles ; injuries ; Female ; Hearing Loss, Mixed Conductive-Sensorineural ; diagnosis ; etiology ; surgery ; Humans ; Male ; Middle Aged ; Ossicular Prosthesis ; Ossicular Replacement ; Young Adult

OBJECTIVETo evaluate the effect of ossicular reconstruction with partial ossicular replacement prosthesis (PORP) in patients with tympanosclerosis.

METHODSThe data of 31 cases of tympanosclerosis treated between 1992 and 2009 were reviewed. Of the 31 patients, 17 (17 ears) underwent ossicular reconstruction with porous macromolecular polyethylene PORP, and 14 (14 ears) with bioceramic PORP. All the patients were followed up for 3-24 months.

RESULTSSignificant improvement was found in postoperative speech frequency (500, 1000, 2000 Hz) pure tone average (PTA) and air-bone gap (ABG) (P < 0.05) after the treatments without statistically significant differences between the two groups (P > 0.05).

CONCLUSIONPorous macromolecular polyethylene and bioceramic are valuable ossicular prosthesis for tympanosclerosis.

Adult ; Biocompatible Materials ; Ceramics ; chemistry ; Female ; Humans ; Macromolecular Substances ; chemistry ; Male ; Middle Aged ; Ossicular Prosthesis ; Ossicular Replacement ; methods ; Otosclerosis ; surgery ; Polyethylene ; chemistry ; Porosity ; Prosthesis Implantation ; methods ; Treatment Outcome